Modification of Cue Reactivity by Neurofeedback in Human Addiction

Central Institute of Mental Health, Mannheim

Status: Unknown

Conditions: Alcohol Use Disorder (AUD)

Treatments: Behavioral: mindfulness-based relapse prevention (MBRP) and NFB; Behavioral: Treatment as usual (TAU) and neurofeedback (NFB); Behavioral: TAU and sham NFB; Behavioral: MBT and sham NFB

Study type: Interventional

Funder types: Other

Identifiers

NCT04366505

TRR265 C04

Details and patient eligibility

About

The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.

Full description

Project C04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fMRI neurofeedback. Firstly, the investigators will test whether a prior mindfulness-based intervention (WP1) is able to enhance the effect of rtfMRI NFB (WP2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. Secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.

Enrollment: 88 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• alcohol use disorder according to DSM-5
• ability to provide fully informed consent and to use self-rating scales
• abstinent after detoxification for at least 5 days
• sufficient understanding of the German language

Exclusion criteria

• lifetime history of DSM-5 bipolar, psychotic disorder, or substance dependence other than alcohol or nicotine dependence
• current substance use other than nicotine and/or mild to moderate recreational use of cannabis as evidenced by positive urine test
• current threshold DSM-5 diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder
• history of severe head trauma or other severe central neurological disorders (dementia, Parkinson's disease, multiple sclerosis)
• pregnancy or nursing infants
• use of medications or drugs known to interact with the CNS within the last 10 days, with testing at least four half-lives post last intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

NFB + (MBRP)

Experimental group

Description:

Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some)

Treatment:

Behavioral: mindfulness-based relapse prevention (MBRP) and NFB

Behavioral: Treatment as usual (TAU) and neurofeedback (NFB)

Behavioral: MBT and sham NFB

TAU and sham NFB

Active Comparator group

Description:

TAU + Neurofeedback (NFB) from control region

Treatment:

Behavioral: TAU and sham NFB